FDA Device recall Z-1954-2026
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (RE…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (RE… by Philips North America, citing the potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1954-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-14 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
Reason
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Identifiers
| code_info | 1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)847…1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)84741. Serial Numbers: 41527, 70949, 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560, (01)00884838108714(21)41277, (01)00884838108714(21)70769, (01)00884838108714(21)70983. Serial Numbers: 84560, 41277, 70769, 70983. 3. Model Number (REF): 782166. UDI: (01)00884838115774(21)70042. Serial Numbers: 70042. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2026%22
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